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December, 2021
Venue & Pricing TBA

Garner Efficiencies in Regulatory and Reimbursement Processes in a COVID Era

The Original Forum for Life Sciences Providing Exclusive Access to FDA/CMS Regulators to Examine Shifting Regulatory and Reimbursement Policy

Who Should Attend

You will benefit from attending this event if you are from a bio/pharma or medical device/diagnostic company with responsibilities or involvement in the following areas:


  • Regulatory Affairs
  • Government Affairs/Relations
  • Health Economics
  • Public Policy & Strategy
  • Payment and Healthcare
  • Quality
  • Patient Advocacy
  • Medicaid
  • Medicare
  • Market Access
  • R&D
  • Drug Safety
  • Rare Disease
  • Compliance
  • Gene Therapy

This conference will also benefit consultants and software providers that provide services to life science companies.

What to Expect


Garner the Latest Regulatory Updates
Garner the Latest Regulatory Updates
  • Discuss FDA and CMS perspectives on the impact of the pandemic on regulatory approval and reimbursement processes — Which efficiency and process shifts are here to stay?
  • Explore trends in decentralization and digital enablement of clinical trials — Identify next steps to achieve diversity in clinical trials
  • Advance cross-center (CBER/CDER) approaches to incorporate patient engagement in regulatory decision-making
  • Consider next steps to realize the full potential of RWE in drug development
Examine the Latest Updates to Reimbursement Policy
Examine the Latest Updates to Reimbursement Policy
  • Understand the current state of value-based reimbursement models in the midst of the pandemic and the impact on the future of value-based care
  • Examine reimbursement status of new technologies and advanced therapies under new payment models
  • Review updates on Medicare coverage and access — Discuss CMS advancements in expanding telehealth benefits and the focus on improving plan incentives to align with what patients value
Political Landscape Shifts and Market Trends that Impact Drug Development
Political Landscape Shifts and Market Trends that Impact Drug Development
  • Assess the impact of the 2020 election on drug pricing reform
  • 21st Century Cures Act 2.0 — Consider the impact on drug development and patient access
  • Address challenges and opportunities in cell and gene therapy development
  • Evaluate the future for the drug development supply chain — What are the potential capabilities and pros/cons of domestic manufacturing?

Connect and Network with Key Decision-Makers at the 2021 FDA/CMS Summit

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